Safety considerations in the treatment with anti-CGRP(R) monoclonal antibodies in patients with migraine.

Background: Anti-CGRP-(receptor-)monoclonal antibodies (anti-CGRP(R)-mAbs) represent a novel class of drugs for migraine treatment, but their long-term cerebrovascular and cardiovascular (CV) safety warrants further examination. Methods: In this observational cohort study we assessed the CV safety for erenumab and fremanezumab in a real-world setting during a follow-up period of at least 1 year. Patients with hypertension or CV history were excluded. We conducted ECGs and collected clinical data at treatment initiation and thereafter every 3 months, including liver and kidney function, lipid-, electrolyte-and glucose levels. Results: Among patients receiving erenumab (n = 101) or fremanezumab (n = 92), 3.1% (6/193) developed abnormal ECGs or CV adverse events. Of these, three (1.6%) experienced moderate to severe CV adverse events (cerebellar stroke, spontaneous coronary artery dissection, and pericarditis) and discontinued treatment. The remaining three (1.6%) developed non-threatening ECG abnormalities without physical complaints. No significant changes were observed in liver and kidney function, lipid-, electrolyte-, or glucose levels. Discussion: We observed CV events in 1.6% of patients with 1.5-year follow-up of anti-CGRP(R)-mAbs treatment. We advise awareness regarding CV events in patients with migraine undergoing CGRP-targeted treatment, not as a confirmation of increased risk but as a proactive measure to address potential multifactorial influences.

3MDR treatment in an adolescent with PTSD: a case report.

Background: As Posttraumatic stress disorder (PTSD) in adolescents significantly impacts their well-being, effective treatment is of great importance. Little is known, however, about the novel, multi-modal virtual reality supported, exposure-based psychotherapeutic interventions such as 3MDR in this population.Objective: To describe the 3MDR treatment of an adolescent with PTSD who did not respond to previous exposure-based PTSD interventions.Method: A 14-year-old girl diagnosed with PTSD received six sessions of 3MDR embedded in family therapy.Result: The patient tolerated the 3MDR intervention very well. Personalized music and self-selected pictures appeared to be a good fit, contributing to enhanced engagement in and adherence to the therapy. She no longer met criteria for PTSD post-intervention, and at 18 months follow-up.Conclusion: This case report suggests that 3MDR has potential as a trauma treatment for adolescents with treatment-resistant PTSD.

Trauma-focused therapy for youngsters is often complicated, with a high percentage of dropouts.Elements of 3MDR such as walking, self-selected pictures, and personalized music are a good fit, contributing to enhanced engagement in and adherence to 3MDR therapy.3MDR has potential as a trauma treatment for adolescents with treatment-resistant PTSD.

The Redesign and Validation of Multimodal Motion-Assisted Memory Desensitization and Reconsolidation Hardware and Software: Mixed Methods, Modified Delphi-Based Validation Study.

BACKGROUND: In recent years, the delivery of evidence-based therapies targeting posttraumatic stress disorder (PTSD) has been the focus of the Departments of Defense in countries such as Canada, the Netherlands, and the United States. More than 66% of military members continue to experience symptoms of PTSD that significantly impact their daily functioning and quality of life after completing evidence-based treatments. Innovative, engaging, and effective treatments for PTSD are needed. Multimodal motion-assisted memory desensitization and reconsolidation (3MDR) is an exposure-based, virtual reality-supported therapy used to treat military members and veterans with treatment-resistant PTSD. Given the demonstrated efficacy of 3MDR in recently published randomized control trials, there is both an interest in and a need to adapt the intervention to other populations affected by trauma and to improve accessibility to the treatment. OBJECTIVE: We aimed to further innovate, develop, and validate new and existing hardware and software components of 3MDR to enhance its mobility, accessibility, feasibility, and applicability to other populations affected by trauma, including public safety personnel (PSP), via international collaboration. METHODS: This study used a modified Delphi expert consultation method and mixed methods quasi-experimental validation with the purpose of software validation among PSP (first responders, health care providers) participants (N=35). A team of international experts from the Netherlands, the United States, and Canada met on the web on a weekly basis since September 2020 to discuss the adoption of 3MDR in real-world contexts, hardware and software development, and software validation. The evolution of 3MDR hardware and software was undertaken followed by a mixed methods software validation study with triangulation of results to inform the further development of 3MDR. RESULTS: This study resulted in the identification, description, and evolution of hardware and software components and the development of new 3MDR software. Within the software validation, PSP participants widely acknowledged that the newly developed 3MDR software would be applicable and feasible for PSP affected by trauma within their professions. The key themes that emerged from the thematic analysis among the PSP included the desire for occupationally tailored environments, individually tailored immersion, and the applicability of 3MDR beyond military populations. CONCLUSIONS: Within the modified Delphi consultation and software validation study, support for 3MDR as an intervention was communicated. PSP participants perceived that 3MDR was relevant for populations affected by trauma beyond military members and veterans. The resulting hardware and software evolution addressed the recommendations and themes that arose from PSP participants. 3MDR is a novel, structured, exposure-based, virtual reality-supported therapy that is currently used to treat military members and veterans with PTSD. Going forward, it is necessary to innovate and adapt 3MDR, as well as other trauma interventions, to increase effectiveness, accessibility, cost-effectiveness, and efficacy among other populations affected by trauma.

Therapist and operator experiences utilizing multi-modal motion-assisted Memory Desensitization and Reconsolidation (3MDR) for treatment of combat related posttraumatic stress disorder amongst military and veteran populations.

Background: As provisions of mental healthcare services to military and veteran populations increases the risk to service providers developing secondary traumatic stress (STS), efforts are needed to examine the impact of delivering novel interventions which may include 3MDR. As a virtual-reality supported intervention, 3MDR exposes the patient, therapist and operator to graphic and sensory stimuli (i.e. narratives, imagery, smells, and music) in the course of the intervention. 3MDR is actively being researched at multiple sites internationally within military and veteran populations. It is, therefore, crucial to ensure the safety and wellbeing of 3MDR therapists and operators who are exposed to potentially distressing sensory stimuli. Objective: The purpose of this study is to qualitatively examine the impact and experiences of STS amongst therapists and operators in delivering 3MDR. For this study, impact will be defined as therapists or operators experiencing perceived STS as a result of delivering 3MDR. Methods: This exploratory qualitative study recruited 3MDR therapists and operators (N = 18) from Canada, the Netherlands, the United Kingdom, and the United States who had previously delivered 3MDR therapy. Telephone or video-conferencing interviews were used to gather data that was subsequently transcribed and thematically analyzed. Results: Four themes emerged among the therapists (n = 13) and operators (n = 5): (1) personal cost and benefits of 3MDR, (2) professional paradox of a 3MDR therapist, (3) perceived effect of 3MDR on patients, and (4) recommendations for future 3MDR use. Conclusions: STS was not noted to be a significant challenge for 3MDR therapists and operators. Future research may investigate optimal means of providing training and ongoing support for 3MDR therapists and operators. HIGHLIGHTS: Secondary Traumatic Stress was not noted to be a significant challenge for 3MDR therapists and operatorsFuture research may investigate optimal means of providing training and ongoing support for 3MDR therapists and operators.

Antecedentes: Dado que la prestación de servicios de atención en salud mental a poblaciones de militares y veteranas aumenta el riesgo de que los proveedores de la atención desarrollen estrés traumático secundario (STS en sus siglas en inglés), se requieren esfuerzos para examinar el impacto de la entrega de intervenciones novedosas que pueden incluir 3MDR. Una intervención de apoyo de realidad virtual, 3MDR expone al paciente, terapeuta y operador a estímulos sensoriales y gráficos (es decir, narrativas, imágenes, olores y música) en el transcurso de la intervención.3MD está siendo investigada activamente en múltiples sitios a nivel internacional dentro de poblaciones militares y de veteranos. Por lo tanto, es crucial garantizar la seguridad y bienestar de los terapeutas y operadores de 3MDR que están expuestos a estímulos sensoriales potencialmente perturbadores. Objetivo: El propósito de este estudio es examinar cualitativamente el impacto y las experiencias de STS entre terapeutas y operadores que entregan 3MDR. Para este estudio, el impacto se definirá como los terapeutas o los operadores experimentan los STS percibidos como resultado de la entrega de 3MDR. Método: Este estudio cualitativo exploratorio reclutó a terapeutas y operadores 3MDR (N = 18) de Canadá, Holanda, Reino Unido y Estados Unidos de Norteamérica, quienes previamente habían dado terapia 3MDR. Se usaron entrevistas telefónicas o por videoconferencias para reunir los datos que luego se transcribieron y analizaron temáticamente. Resultados: Emergieron 4 temas entre los terapeutas (N = 13) y operadores (N = 5): (1) costo personal y beneficios de 3MDR, (2) paradoja profesional de un terapeuta 3MDR, (3) efecto percibido de 3MDR en los pacientes, y (4) recomendaciones para el uso futuro de 3MDR. Conclusiones: No se notó que STS fuera un desafío significativo para los terapeutas y operadores de 3MDR. Investigaciones futuras pueden investigar medios óptimos para proporcionar formación y apoyo continuo para los terapeutas y operadores 3MDR. Destacados: No se observó que el Estrés Traumático Secundario fuera un desafío significativo para los terapeutas y operadores 3MDR. Investigaciones futuras pueden investigar medios óptimos para proporcionar formación y apoyo continuo para los terapeutas y operadores 3MDR.